Balloon kyphoplasty more effective than non-surgical treatment in cancer patients with VCF

Study Type: Therapy
OE Level of Evidence: 2
Journal Level of Evidence: N/A
134 patients with metastatic bone disease and a vertebral compression fracture (VCF) were randomized to be treated with either balloon kyphoplasty or a standard non-surgical treatment (control group) to compare the effects of these treatments on pain, function and quality of life. Results indicated that the kyphoplasty group had significantly better improvements in function, quality of life, reduced activity days, bed rest days, and analgesic consumption compared to the control group at 1 month. The kyphoplasty group Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Industry funded
Sponsor: Medtronic Spine LLC
Conflicts: Other
Why was this study needed now?
It is not uncommon for individuals will solid tumours or myeloma to suffer from generalized bone loss or weakening. This is due to the progression of their disease and also as a direct result of their prescribed treatment regimen. Consequently, there is a dramatic increase in the risk for fractures in these patients, most notably vertebral compression fractures (VCF). Treatment of VCFs can consist of surgical or non-surgical methods, with open surgery being reserved for those with neurological deficit due to the poor bone conditions often observed in this population. Furthermore, non-surgical treatment may yield unwanted side-effects. Thus, minimally-invasive balloon kyphoplasty has been suggested as an alternative treatment for VCFs and has not yet been investigated as a randomized clinical trial.
What was the principal research question?
How did balloon kyphoplasty compare to non-surgical treatment in terms of efficacy and safety in patients suffering from cancer and vertebral compression fractures, when assessed at 12 months?
Population: 134 patients (21 years or older) suffering from cancer and one to three painful VCFs (from T5 to L5). Cases of osteoblastic tumours, primary bone tumours, or plasmacytoma at the index VCF were excluded.
Intervention: Balloon kyphoplasty group: Patients in this group (n=70, 40 completed final follow up) underwent balloon kyphoplasty with the use of introducer tools, inflatable bone tamps, and polymethylmethacrylate bone cement and delivery devices (Medtronic Spine, Sunnyvale, CA, USA). The procedure could be performed using the percunateous, bilateral, transpedicular or extrapedicular method. If needed, patients were allowed to receive analgesics, bed rest, bracing, physiotherapy, other rehabilitation programs, walking aids, radiation treatment, or other forms of anti-tumour therapy (Mean age = 64.8 years (37.6-88.0); 59% female)
Comparison: Non-surgical treatment group: Patients in this group (n=64, 24 completed final follow up) underwent standard non-surgical treatment. Therefore, they received bed rest, bracing, physiotherapy, other rehabilitation programs, walking aids, radiation treatment, or other forms of anti-tumour therapy. In addition, they were allowed to consume analgesics (Mean age = 63.0 years (39.5-83.4); 57% female)
Outcomes: The primary outcome was the Roland-Morris disability questionnaire (RDQ). Secondary outcomes included the Karnofsky performance status (KPS) score, the Short-Form Health Survey (SF-36), a numerical rating scale (NRS) for back pain, analgesic consumption, the number of reduced activity days, the number of bed rest days, the incidence of subsequent radiographic VCFs, as well as the incidence of adverse and serious adverse events.
Methods: RCT: Multi-center
Time: Outcomes were assessed at 1, 3, 6 and 12 months.
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.